Vibrotactile Foot Device for Freezing of Gait in Parkinson's Disease

Capital Medical University

Status: Enrolling

Conditions: Freezing of Gait; Parkinson Disease

Treatments: Device: Vibrotactile foot device (Smart shoe)

Study type: Interventional

Funder types: Other

Identifiers

NCT06147713

Vibrotactile Foot Device

Details and patient eligibility

About

Freezing of gait (FOG) is a common, disabling symptom of later stage Parkinson's disease (PD), and can induce significant morbidity and mortality by increasing risk of falls as the disease progresses. Despite optimum medical management and deep brain stimulation therapy, many patients with PD are incapacitated by FOG and gait disorders. Non-invasive vibrotactile stimulation has been reported to potentially improve FOG of patients with PD. However, results of studies were variable, and there is a lack of convenient vibrotactile devices ready for daily use with reliable clinical trial data. In the proposed study, the investigator will test the effect of a newly developed vibrotactile foot device (Smart shoe) on participants diagnosed with PD and FOG. EEG and fMRI are obtained in order to investigate the underlying neurological mechanism.

Enrollment: 200 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 30-80 years
• Diagnosed with Parkinson's Disease according to MDS Clinical Diagnostic Criteria
• Stable drug therapy without any change in the past one month
• Subjective presence of FOG more than once per day
• Objective presence of FOG by provoking tasks, e.g., gait initiation, rapid full turn, et al.
• Able to walk unaided at least 20 meters
• Provide written informed consent

Exclusion criteria

• Stroke and other diseases interfering ambulation
• Severe foot sensory impairments disabling the individual to perceive vibratory stimulation
• History of deep brain stimulation surgery

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Intervention

Experimental group

Description:

The subjects will be examined during the drug-off period with the vibrotactile foot device off and on at different patterns. The tests will be carried out during the onsite clinical visits on the day of initial enrollment and two weeks after home wearing.

Treatment:

Device: Vibrotactile foot device (Smart shoe)